ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 29, 2016 No. 908

About modification of some decisions of the Government of the Republic of Kazakhstan

The government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed changes which are made to some decisions of the Government of the Republic of Kazakhstan.

2. This resolution becomes effective from the date of its first official publication, but not earlier than January 1, 2017.

 

Approved by the Order of the Government of the Republic of Kazakhstan of December 29, 2016 No. 908

Changes which are made to some decisions of the Government of the Republic of Kazakhstan

1. In the order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729 "About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care" (SAPP of the Republic of Kazakhstan, 2009, Art. No. 47-48, 444):

state heading in the following edition:

"About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance";

state Item 1 in the following edition:

"1. Approve the enclosed Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services for rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance.";

Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care, approved by the specified resolution to be reworded as follows according to appendix 1 to these changes.

2. In the order of the Government of the Republic of Kazakhstan of November 7, 2009 No. 1781 "About the single distributor performing within the guaranteed amount of free medical care purchase of medicines, products of medical appointment, services in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, long-term agreements, and also the organization of purchase of medical equipment":

state heading in the following edition:

"About the single distributor performing within the guaranteed amount of free medical care and medical care in system of compulsory social insurance purchase of medicines, products of medical appointment, services in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, long-term agreements, and also the organization of purchase of medical equipment";

state Item 1 in the following edition:

"1. Determine SK-Pharmation limited liability partnership the single distributor by purchase of medicines, products of medical appointment, services in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, long-term agreements, and also the organization of purchase of medical equipment within the guaranteed amount of free medical care and medical care in system of compulsory medical insurance.".

3. In the order of the Government of the Republic of Kazakhstan of July 8, 2015 No. 515 "About approval of Rules of purchase of services in storage and transportation of medicines and products of medical appointment within the guaranteed amount of free medical care by the single distributor and modification and amendments in some decisions of the Government of the Republic of Kazakhstan" (SAPP of the Republic of Kazakhstan, 2015, Art. No. 37-38, 265):

state heading in the following edition:

"About approval of Rules of purchase of services in storage and transportation of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and system of compulsory social medical insurance and modification and amendments in some decisions of the Government of the Republic of Kazakhstan";

The rules of purchase of services in storage and transportation of medicines and products of medical appointment within the guaranteed amount of free medical care by the single distributor approved by the specified resolution to be reworded as follows according to appendix 2 to these changes.

Appendix 1

to Changes which are made to some decisions of the Government of the Republic of Kazakhstan

Approved by the Order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729

Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance

Section 1. Basic provisions

Chapter 1 General provisions

1. These rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance (further – Rules) articles 6, the subitem 7) of article 10 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further – the Code), Item 2 of article 7 of the Law of the Republic of Kazakhstan of November 16, 2015 "About compulsory social medical insurance" are drafted according to the subitem 12) and determine procedure for the organization and carrying out purchase of medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance, and also acquisition of medical equipment by the lessor through the single distributor for further transfer of health care to the organizations on the terms of financial leasing.

2. In these rules the following concepts are used:

1) the affiliate of the customer or the organizer of purchase or the single distributor - person (except for the state bodies performing regulation of its activities within the conferred powers) who has opportunity directly and (or) indirectly to determine decisions and (or) to exert impact on accepted by the customer, the organizer of purchase or the single distributor of the decision, including owing to the agreement, and also any person concerning whom the customer or the organizer of purchase or the single distributor have such right;

2) the affiliate of the potential supplier - physical person or legal entity which has the right directly and (or) to indirectly determine decisions and (or) to exert impact on the decisions made by this potential supplier, including owing to the agreement or other transaction, and also physical person or legal entity concerning which this potential supplier has such right;

3) customers are administrators of budget programs of health care, public institutions, fund of compulsory social medical insurance (further - fund), and also the state companies, legal entities, fifty and more percent of voting shares (shares) of which belong to the state;

4) the single distributor – the legal entity performing within the guaranteed amount of free medical care and in system of compulsory social medical insurance purchase of medicines, products of medical appointment, service in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, including long-term agreements, and also the organization of purchase of medical equipment;

5) purchase – acquisition by the customer, single distributor, lessor of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance according to the procedure and the methods established by these rules;

6) expert evaluation – assessment performed by the lessor according to technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for the medical equipment approved by authorized body in the field of health care;

7) medicine – the means representing or containing pharmacological the active agents coming into contact with human body or getting into its bodies and fabrics intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal raw materials, balk-products of medicines, medicines;

8) immunobiological medicines – medicines for specific prevention, diagnostics and treatment of infectious and immune diseases (including allergic) by means of immunological methods of other diseases and physiological conditions, means for indication of infectious agents and their antigens in objects of external environment, blood medicines (irrespective of obtaining method), and also the medicines rendering medical and preventive effects through immune system;

9) medical equipment - the devices, devices and the equipment used separately in complexes or systems in the medical purposes for prevention, diagnostics, treatment of diseases, rehabilitation, scientific research of medical nature;

10) products of medical appointment - the products, materials used for holding preventive, diagnostic and medical actions: the medical tools, dental, consumable, dressing and sutural materials fixing bandages and devices, products of medical optics;

11) homogeneous goods and services - goods and services which, without being identical, have similar characteristics and consist of similar components that allows them to perform the same functions and to be interchangeable;

12) биосимиляр – biotechnological medicine, similar with (original) medicine made for the first time on quality, safety, efficiency and provided on registration after expiration of the patent of original medicine;

13) the potential supplier – the physical person performing business activity, the legal entity (except for public institutions if other is not established for them by the laws of the Republic of Kazakhstan), applying for the conclusion of the agreement according to these rules;

14) the supplier – the physical person performing business activity, the legal entity (except for public institutions, if other is not established for them the laws of the Republic of Kazakhstan) who signed the agreement according to these rules or the agreement of financial leasing according to legal acts of the Republic of Kazakhstan for financial leasing;

15) the tender – the purchase method providing open competition between potential suppliers and directed to determination of the most advantageous conditions of the agreement on purchase;

16) the tender with use of two-stage procedures (further – the two-stage tender) – the purchase method providing open competition between potential suppliers and directed to determination of the most advantageous conditions of the agreement using the auction performed according to these rules;

17) the tender documentation – documentation submitted by the customer or the organizer of the tender to the potential supplier for preparation of the tender according to these rules;

18) the tender – the proposal of the potential supplier constituted according to the tender documentation or provisions of these rules;

19) the organizer of purchase - person determined by the customer who organizes purchase by the methods provided by these rules and sends purchase results to the customer for the conclusion of the agreement of purchase or the contract for rendering pharmaceutical services;

20) domestic producer – the physical person or legal entity performing business activity, being resident of the Republic of Kazakhstan and making the goods, ready to the use (application), which are completely made or processed in the Republic of Kazakhstan according to criteria of sufficient conversion, confirmed with authorized body on issue of the certificate of origin for the internal address of "CT-KZ";

21) foreign producer (manufacturing plant) - the foreign legal entity created by the legislation of foreign state, who is the nonresident of the Republic of Kazakhstan and making the goods, ready to the use (application), which are completely made or processed outside the Republic of Kazakhstan, confirmed in accordance with the established procedure with certificates of origin;

22) the list of the medicines, products of medical appointment and medical equipment which are purchased from the single distributor (further – the list of the single distributor) – the document developed and approved by authorized body in the field of health care containing:

the list of medicines, the products of medical appointment which are purchased by customers from the single distributor with indication of the international non-proprietary name or composition of medicines, and also technical characteristic and marginal prices, possibility of the conclusion of the long-term agreement of delivery with domestic producers;

the list of medicines with indication of the international non-proprietary name for provision of medicines of patients with individual intolerance and realization of the principle of patsiyentooriyentirovannost of the medicinal help;

the list and technical characteristics of medical equipment according to each name;

23) authorized body in the field of the state support of industrial and innovative activities – the central executive body performing management in spheres of the industry and industrial and innovative development, development of the pharmaceutical and medical industry of the country, the state investment policy and policy of support of investments;

24) residents of the Republic of Kazakhstan - the legal entities or physical persons performing business activity, registered according to the civil and tax legislation of the Republic of Kazakhstan;

25) nonresidents of the Republic of Kazakhstan - the foreign physical persons and legal entities which are not residents of the Republic of Kazakhstan according to the civil and tax legislation of the Republic of Kazakhstan;

26) fixed price – the price of medicine, product of medical appointment determined by results of purchase at which the supplier shall deliver medicines, products of medical appointment to the single distributor;

27) pharmaceutical service in rendering the guaranteed amount of free medical care – the activities of subjects in the field of drug circulation, products of medical appointment connected with providing the population with medicines, products of medical appointment including purchase, transportation, storage, realization (prescription dispensing) and accounting;

28) selling price - the price of the provided medicines, specialized medical products, products of medical appointment established by results of purchase of pharmaceutical services within one administrative and territorial unit (area, the city of republican value, the capital);

29) cost recovery - compensation of public administration by local authorities health care of areas, the cities of republican value, the capital (further - local authorities of management of health care) and (or) fund to the supplier of cost of pharmaceutical service;

30) the long-term agreement of supply of medicines, products of medical appointment – the civil agreement signed by the single distributor for up to 10 years:

with the legal entity – the resident of the Republic of Kazakhstan on supply of medicines, the products of medical appointment made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for the products of medical appointment having the certificate of origin for the internal address according to the legislation of the Republic of Kazakhstan;

or with the legal entity having intention on creation of production of medicines, products of medical appointment according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment;

31) guarantee field service – the range of services on maintenance of the delivered medical equipment in good repair including any kinds of maintenance, technical diagnostics and fault detection of the equipment, rescue and recovery operations, technical consultations and training which are rendered by the supplier (the manufacturer, the contractor) on condition of its proper use and storage is free for the term defined by agreements of purchase, long-term agreements of delivery and financial leasing, except for recoveries of consumable materials and the worn-out nodes;

32) the agreement of financial leasing – the tripartite agreement according to which the lessor shall acquire in property the leasing subject specified by the leasing recipient at the supplier according to these rules and provide to the leasing recipient this subject of leasing in temporary ownership and use for a fee according to the civil legislation of the Republic of Kazakhstan;

33) the agreement of purchase – the agreement signed between the customer and the supplier on the purchase of goods according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties with all appendices and amendments to it, and also all documentation on which in the agreement there are references;

34) the delivery agreement - the agreement signed between the single distributor and the supplier on the purchase of medicines, products of medical appointment according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties with all appendices and amendments to it, and also all documentation on which in the agreement there are references;

35) the agreement of purchase - the agreement signed between the single distributor and the customer on the purchase of medicines, products of medical appointment according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties with all appendices and amendments to it, and also all documentation on which in the agreement there are references;

36) the agreement on rendering pharmaceutical services - the agreement signed between the customer and the supplier on the purchase of pharmaceutical services according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties with all appendices and amendments to it, and also all documentation on which in the agreement there are references;

37) kliniko-technical reasons – the document containing information on the need for required medical equipment and readiness of the organization of health care it to apply;

38) the lessor – the legal entity, the participant of the leasing transaction who by the attracted and (or) own money acquires subject of leasing in property and gives him to the leasing recipient on terms of the contract of financial leasing;

39) the leasing recipient – the organization of health care (the participant of the leasing transaction) which accepts leasing subject on terms of the contract of financial leasing;

40) leasing payments – the periodical payments representing the total amount of payments under the agreement of financial leasing for all duration of the agreement of financial leasing which shall be calculated taking into account compensation of all cost of subject of leasing at the price of the moment of the conclusion of the agreement of financial leasing, and performed throughout the duration of the agreement of financial leasing which include:

compensation to the lessor of purchase costs of subject of leasing and any other expenses which are directly connected with acquisition, delivery of subject of leasing and its reduction in the working condition for proper use according to the agreement of financial leasing;

remuneration on leasing;

41) the medical equipment requiring unification – the medical equipment with uniform technical characteristics which is purchased by the organizations of health care for rendering homogeneous medical services at the expense of means of the republican budget including target current transfers to regional budgets, budgets of the cities of Astana and Almaty on material equipment of the medical organizations at the local level;

42) leasing term – the term for which the subject of leasing is provided to the leasing recipient in temporary ownership and use according to the agreement of financial leasing at the same time early agreement cancelation of financial leasing in case of reservation of ownership right regarding leasing for the lessor does not involve change of term of leasing;

43) the investment project – complex of the actions providing investments on creation new and (or) upgrade of the operating productions of medicines according to standards of proper production practice (GMP) and products of medical appointment according to the ISO standards;

44) the long-term agreement of delivery of medical equipment – the civil agreement signed by the single distributor with the legal entity – the resident of the Republic of Kazakhstan for up to seven years on delivery of the medical equipment made according to requirements of international standards and having the certificate of origin for the internal address according to the legislation of the Republic of Kazakhstan;

45) the price list of the single distributor – the price offer approved by the single distributor for customers, containing list of the medicines which were purchased by it, products of medical appointment with indication of the international non-proprietary name or structure, the trade name, dosage form (technical characteristic), unit of measure, packing, the producer (country), unit price taking into account markup of the single distributor;

46) orphan medicines – medicines for treatment and diagnosis of orphan (rare) diseases;

47) the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization) – the republican state company on the right of economic maintaining performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and also scientific research in the field of development of new original medicines, pharmacy, pharmacology;

48) the supplier of pharmaceutical service – the subject rendering services in providing with medicines and products of medical appointment based on the contract with local body of health care and (or) fund according to the procedure and the methods determined by these rules;

49) information system of the single distributor – the information system determined by the single distributor automating activities of the single distributor and allowing message exchange of electronic documents with all concerned parties of process of distribution;

50) the digital signature – set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;

51) the electronic document – the document in which information is provided in electronic and digital form and is certified by means of the digital signature;

52) fund of social medical insurance (further – fund) – the non-profit organization making accumulation of assignments and fees, and also performing purchase and fee of the subjects of health care providing medical care in amounts and on the conditions provided by the agreement of purchase of medical services;

53) goods – medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and (or) medical equipment;

54) the state register of medicines, products of medical appointment and medical equipment - the document of accounting of the medicines registered by the expert organization and allowed for medical application in the Republic of Kazakhstan, products of medical appointment and medical equipment (further – the state register);

55) the international unlicensed name of medicine (further - MNN) - the name of medicine recommended by the World Health Organization;

56) the collaborator - the physical person performing business activity, or the legal entity involved by the potential supplier for joint agreement performance about rendering pharmaceutical services;

57) the passing remaining balance – medicines and (or) the products of medical appointment accepted last financial years from suppliers on warehouse of the single distributor, but not realized to customers;

58) the countries of regions of ICH - member countries of the International conference on harmonization of technical requirements to registration of medicines for the person.

Chapter 2. The principles, methods and restrictions connected with purchase

3. The purchase is made with respect for the principles:

1) optimum and effective expenditure of the money used for purchase;

2) provisions to potential suppliers of equal opportunities for participation in the procedure of carrying out purchase;

3) fair competition among potential suppliers;

4) publicity and transparency of process of purchase;

5) supports of domestic producers;

6) supports of entrepreneurial initiative;

7) patsiyentooriyentirovannost of the medicinal help.

4. For the purpose of optimum and effective expenditure of the budgetary funds allocated for purchase of medicines, the products of medical appointment intended for rendering the guaranteed amount of free medical care, medical care in system of compulsory social medical insurance, medicines products of medical appointment are bought at the prices which are not exceeding established by authorized body.

5. Ceiling prices for medicines, products of medical appointment according to the list of the single distributor annually till June first of the corresponding financial year affirm authorized body.

6. The purchase is performed by the customer or the organizer of purchase by one of the following methods:

1) tender;

2) request of price offers;

3) from one source;

4) at the single distributor according to its list;

5) through the single distributor on acquisition of medical equipment;

6) acquisitions of medical equipment on the terms of financial leasing according to the procedure, the established legal acts of the Republic of Kazakhstan for financial leasing of health care by the organizations, except for public institutions.

7. The single distributor the purchase is performed by one of the following methods:

1) two-stage tender;

2) from one source;

3) special procedure of purchase of medicines, products of medical appointment for the prevention of origin and spread of infectious and parasitic diseases, prevention and elimination of effects of emergency situations;

4) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having intention on creation of production of medicines, products of medical appointment;

5) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having production of medicines, products of medical appointment;

6) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having production on medical equipment.

8. The lessor performs purchase of medical equipment for further transfer of health care to the organizations on the terms of leasing through the single distributor.

9. Workers, and also affiliates of the customer, the organizer of purchase, the single distributor or the lessor do not participate in quality of potential suppliers when implementing the purchase regulated by these rules.

The potential supplier and his affiliate do not act as the participant of the tender for one lot.

The potential supplier does not participate in purchase if:

1) close relatives, the spouse (spouse) or cousins-in-laws of the first heads of the potential supplier and (or) the authorized representative of the potential supplier have power of decision about the choice of the supplier or are customer representative or the organizer of purchase in the carried-out purchase;

2) the head of the potential supplier, the founder of the legal entity, and also the physical person performing business activity who apply for participation in purchase had relations connected with management, organization, participation in the authorized capital of the legal entities included in the list of unfair potential suppliers or suppliers;

3) the head of the potential supplier applying for participation in purchase is the physical person performing business activity which is included in the list of unfair potential suppliers or suppliers;

4) the potential supplier who is the physical person performing business activity, applying for participation in purchase is the head of the potential supplier included in the list of unfair potential suppliers (suppliers);

5) the potential supplier consists in the list of unfair potential suppliers (suppliers);

6) financial and economic activities of the potential supplier or supplier are suspended according to the legislation of the Republic of Kazakhstan or the legislation of the state of the potential supplier – the nonresident of the Republic of Kazakhstan.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info